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510(k) Data Aggregation
(231 days)
KardiFlex™ PTCA Balloon Dilatation Catheter is indicated for:
-balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
-balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.
The KardiFlex™ PTCA Balloon Dilatation Catheter is designed to allow rapid exchange of the catheter using a standard length of 0.014" guide wire. Balloon diameters range from 1.5mm to 4.0mm and lengths from 6mm to 30mm. The balloon material is made of compliant material and balloons have a rated burst pressure of 16 atmospheres. The compliant material allows high pressure dilatation while maintaining precise control of the balloon diameter and length.
The KardiFlex™ PTCA Balloon Dilatation Catheter is a sterile, single use and non-pyrogenic device. The balloon has one (for Ø1.5mm) or two (for Ø2.0-4.0mm) radiopaque platinum marker(s) to aid in positioning the balloon in the stenosis and is designed to provide an expandable segment of known diameter and length of a specific pressure. The dilatation catheter is coated with hydrophilic coating, which is activated when wet. The proximal shaft of the catheter is composed of a female luer connector (hub) bonded to a PTFE coated stainless steel tube (hypotube).
The KardiFlex "10 PTCA Balloon Dilatation Catheter consists of 10 parts: hub, strain relief, hypotube, distal outer body, inner body, balloon, radiopaque platinum marker band, tip, balloon sheath and stylet.
The acceptance criteria for the KardiFlex™ PTCA Balloon Dilatation Catheter are based on a comprehensive set of performance tests, as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010). These tests ensure the device's reliable design, performance, and suitability for its intended use.
Here's a breakdown of the acceptance criteria and reported device performance based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test / Acceptance Criteria | Reported Device Performance (KardiFlex™ PTCA Balloon Dilatation Catheter) |
|---|---|---|
| Material Properties | Biocompatibility: | |
| - In vitro cytotoxicity (per ISO 10993-5: 2009) | Performed, implied compliant | |
| - Intracutaneous reactivity (per ISO 10993-10: 2010) | Performed, implied compliant | |
| - Skin sensitization (per ISO 10993-10: 2010) | Performed, implied compliant | |
| - Acute systemic toxicity (per ISO 10993-11: 2017) | Performed, implied compliant | |
| - Hemocompatibility (Hemolysis, Coagulation, Platelet count or leukocyte count, In Vivo Thromboresistance and Complement, per ISO 10993-4: 2017) | Performed, implied compliant | |
| - Material mediated pyrogenicity (per ISO 10993-11: 2017 and USP General Chapter ) | Performed, implied compliant | |
| Physical Dimensions & | Dimensional Verification: | |
| Features | - Balloon diameter: 1.5-4.0mm (per ISO 10555-1: 2013, ISO 10555-4: 2013 and FDA guidance) | Identical to predicate device |
| - Balloon length: Range from 6mm to 30mm (per ISO 10555-1: 2013, ISO 10555-4: 2013 and FDA guidance) | Within range (6-30mm), Identical to Reference device 2 | |
| - Working length: 142.5cm | 142.5cm (Difference to predicate noted as not raising new safety/effectiveness questions) | |
| - Tip Configuration (per ISO 10555-1: 2013) | Performed, implied compliant | |
| - Surface (per ISO 10555-1: 2013) | Performed, implied compliant | |
| - Radio-detectability of Balloon Position (per ISO 10555-1: 2013, ISO 10555-4: 2013 and FDA guidance) | Pass test | |
| - Hub (per ISO 10555-1: 2013) | Performed, implied compliant | |
| Functional | Balloon Rated Burst Pressure: 16atm (per ISO 10555-4: 2013 and FDA guidance) | 16atm (Identical to Reference device 3) |
| Performance | - Balloon Failure Mode (per ISO 10555-4: 2013) | Performed, implied compliant |
| - Balloon Fatigue (per ISO 10555-4: 2013 and FDA guidance) | Pass test | |
| - Diameter at Nominal Pressure (per ISO 10555-4: 2013) | Performed, implied compliant | |
| - Balloon Compliance (per ISO 10555-4: 2013 and FDA guidance) | Pass test | |
| - Inflation Time (per FDA guidance) | Pass test | |
| - Deflation Time (per ISO 10555-4: 2013 and FDA guidance) | Pass test | |
| - Catheter Bond Strength (per ISO 10555-1: 2013 and FDA guidance) | Pass test | |
| - Entry Tip Crossing Profile | Performed, implied compliant | |
| - Balloon Preparation, Deployment and Retraction (per FDA guidance) | Pass test | |
| - Tip Pull Test (per FDA guidance) | Pass test | |
| - Flexibility and Kink Test (per FDA guidance) | Pass test | |
| - Torque Strength (per FDA guidance) | Pass test | |
| - Coating Integrity (per FDA guidance) | Pass test | |
| - Particulate Evaluation (per FDA guidance, EN ISO 8536-4: 2020, USP ) | Pass test | |
| - Shaft Loose Part | Performed, implied compliant | |
| - Freedom from Leakage (per ISO 10555-1: 2013 and product characteristics) | Performed, implied compliant | |
| - Shaft burst | Pass test (Identical to Reference device 2) | |
| Sterilization & | EtO Sterilization: (per ISO 10993-7: 2008 and FDA guidance) | Performed, implied compliant |
| Packaging | - Sterility (per ISO 11135: 2014 and FDA guidance) | Performed, implied compliant |
| - Bacterial Endotoxin (per ANSI/AAMI ST72: 2011) | Performed, implied compliant | |
| - Package Labeling (per ISO 10555-1: 2013, ISO 10555-4: 2013 and FDA guidance) | Performed, implied compliant | |
| - Shelf Life: 2 years (per FDA guidance) | 2 years (Identical) | |
| - Package Seal Verification (per ISO 11607-1: 2019 and ISO 11607-2: 2019) | Performed, implied compliant | |
| - Shipping and Handling (per ISTA 3A: 2018) | Performed, implied compliant | |
| - Chemical performance (per ISO 8536-4: 2019) | Performed, implied compliant |
The reported device performance consistently states "Pass test" or "Performed, implied compliant" for all listed tests, indicating that the KardiFlex™ PTCA Balloon Dilatation Catheter met the specified acceptance criteria for each test according to the FDA guidance and ISO standards.
2. Sample Size for the Test Set and Data Provenance
The provided document details various bench tests and biocompatibility tests. It does not mention clinical trials with human subjects or a "test set" in the context of diagnostic performance (e.g., imaging studies). Therefore, information on sample size for a test set, data provenance (country of origin, retrospective/prospective), number of experts, and adjudication methods are not applicable to the type of testing described in this 510(k) summary, which focuses on the physical and biological characteristics of the medical device itself.
The tests are laboratory-based and include:
- Biocompatibility Testing: Performed per ISO 10993-1: 2018 and FDA guidance.
- Bench Testing (Zero Time and Accelerated Aged): Performed per various ISO standards (e.g., ISO 10555-1, ISO 10555-4) and FDA guidance.
The provenance of this data is from the manufacturer's (Medcaptain Life Science Co., Ltd.) internal testing or contracted laboratories, as part of their submission to the FDA. The country of origin for the submitter is China.
3. Number of Experts and Qualifications for Ground Truth
Not applicable, as this is a medical device (catheter) and the "ground truth" refers to the physical and biological properties being tested against established engineering and biocompatibility standards, not diagnostic interpretations.
4. Adjudication Method for the Test Set
Not applicable. The tests are quantitative measurements and qualitative assessments against predefined pass/fail criteria according to international standards and FDA guidance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a medical device (catheter) for interventional procedures, not a diagnostic AI algorithm that would typically undergo MRMC studies to compare human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. There is no AI algorithm being evaluated. The device performance relates to its physical and biological attributes.
7. Type of Ground Truth Used
The "ground truth" for the tests described is based on established international standards (ISO, USP, ANSI/AAMI) and FDA guidance documents for physical, mechanical, and biological properties of PTCA catheters. For example, balloon burst pressure is measured against a specified atmosphere (16 atm), and biocompatibility is assessed against the criteria outlined in ISO 10993. These are objective scientific and engineering benchmarks.
8. Sample Size for the Training Set
Not applicable. There is no AI algorithm to be trained.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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